Management of Health-Related QoL Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B

Haemophilia A Clinical Trial

— MIND  

Official title:

Management of Health-Related Quality of LIfe Impairment, Including Pain, Depression and Anxiety, in People With Haemophilia A and B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03276130
• Other study ID #: Sobi.HAEM89-003
• Status: Completed
• Start date: October 30, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2024
• Source: Swedish Orphan Biovitrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The puropse of this non-interventional register and survey study is to identify the patterns of prescribed pain, anti-depressive and anti-anxiety medication and management of pain, depression and anxiety for people with haemophilia. The study will be conducted in the Nordic countries (Sweden, Norway, Denmark, Finland) and the aim is to cover the entire haemophilia population in the register part of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2300
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Part A population will be defined by having:

• at least one health care contact with main diagnosis haemophilia A or haemophilia B, and/or;

• at least one prescription of factor VIII or factor IX concentrates, or;

• bypassing agents used in the treatment of PwH during the inclusion period.

• Part B1 population: Relevant physician at each HTC with direct and frequent patient contact.

• Part B2 population: PwH 5 years or older listed at participating HTCs

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• Haemophilia A
• Haemophilia B
• Hemophilia A
• Hemophilia B

Locations

Country	Name	City	State
Denmark	Swedish Orphan Biovitrum Research Site	Copenhagen
Finland	Swedish Orphan Biovitrum Research Site	Helsinki
Sweden	Swedish Orphan Biovitrum Research Site	Göteborg
Sweden	Swedish Orphan Biovitrum Research Site	Malmö
Sweden	Swedish Orphan Biovitrum Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Swedish Orphan Biovitrum

Countries where clinical trial is conducted

Denmark,  Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of medication for pain, depression and anxiety (yes/no?)	Based on Registry data	Retrospectively 10 years
Primary	Annualised consumption of pain medications as assessed by filled prescription	Based on Registry data	Retrospectively 10 years
Primary	Annualised consumption of anti-anxiety medications as assessed by filled prescription	Based on Registry data	Retrospectively 10 years
Primary	Annualised consumption of anti-depressive medications as assessed by filled prescription	Based on Registry data	Retrospectively 10 years
Primary	Duration of pain medications as measured by expected doses of medicines.	Based on Registry data	Retrospectively 10 years
Primary	Duration of anti-depressive medications as measured by expected doses of medicines.	Based on Registry data	Retrospectively 10 years
Primary	Duration of anti-anxiety medications as measured by expected doses of medicines.	Based on Registry data	Retrospectively 10 years
Primary	Pharmacological and non-pharmacological treatments for management of Health-Related Quality of Life (HRQoL) impairment, including treatment of pain	Assessed by Health Care Professional (HCP) survey in Part B1	Inclusion in survey study
Primary	Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of anxiety	Assessed by HCP survey in Part B1	Inclusion in survey study
Primary	Pharmacological and non-pharmacological treatments for management of HRQoL impairment, including treatment of depression	Assessed by HCP survey in Part B1	Inclusion in survey study
Primary	The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of pain at each Haemophlia Treatment Centre	Assessed by HCP survey in Part B1	Inclusion in survey study
Primary	The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of anxiety at each Haemophlia Treatment Centre	Assessed by HCP survey in Part B1	Inclusion in survey study
Primary	The perspective and experience of HCPs with direct and frequent patient Contacts on the strategies for the management of HRQoL impairment, including treatment of depression at each Haemophlia Treatment Centre	Assessed by HCP survey in Part B1	Inclusion in survey study
Primary	Self-reported current and previous use of medications for pain	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Self-reported current and previous use of medications for anxiety	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Self-reported current and previous use of medications for depression	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Social and physical activity level	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Euro-QoL 5 Dimensions 5 Levels (EQ-5D-5L)	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Patient satisfaction with current management of pain	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Patient satisfaction with current management anxiety	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Patient satisfaction with current management of depression	Assessed by patient survey in Part B2	Inclusion in survey study
Primary	Patient satisfaction of received treatment for pain	Assessed by patient survey in Part B2	Inclusion in Survey study
Primary	Patient satisfaction of received treatment for anxiety	Assessed by patient survey in Part B2	Inclusion in Survey study
Primary	Patient satisfaction of received treatment for depression	Assessed by patient survey in Part B2	Inclusion in Survey study